• The Journal of Korean Medicine
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• v.38 no.1
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• pp.93-111
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• 2017

Objectives: The aim of this study is to make evidence-based data for developing a traditional Korean medicine clinical practice guideline for acute bronchitis. Methods: We searched 3 international databases(PubMed, EMBASE, CENTRAL) and 7 domestic databases (KoreaMed, Kmbase, NDSL, KISS, KISTI, OASIS, KoreaTK) to identify randomized controlled trials (RCTs) of acute bronchitis using medicine in recent 10 years. The chosen trials were analyzed by their study design, age range, intervention group, control group, primary and second outcome measure, inclusion and exclusion of participants and adverse events. Results: 15 RCTs are finally included in this study and most of their medications are herbal medicine. For diagnosis and outcome measure of acute bronchitis, Bronchitis Severity Score(BSS) was mostly used. Other measurements eligible are coughing fits, quality of life scale, sputum viscosity, change of individual symptoms and patient's satisfaction. Test duration was for average 7days and safety assessment was held by recording adverse events. Except for anti-inflammatory and antibiotic trials, all medications are found to be effective and well-tolerated. General risk of bias of chosen trials is evaluated low. Conclusions: A well designed clinical trials for traditional Korean medicine of acute bronchitis is needed and this study is expected to make it available.

• Korean Journal of Acupuncture
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• v.35 no.2
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• pp.47-55
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• 2018

Objectives: Clinical improvements can be observed following placebo administrations in clinical trials. Randomized controlled trials have been conducted to disentangle the specific effects of therapeutic interventions over the past decade. In acupuncture trials, non-penetrating placebo needles offer the opportunity to determine the specific effects of needling. Methods: The present review provides an overview of the concept of the placebo effect and the characteristics of the placebo needles. Results: Placebo control can contribute to minimize for bias and the contextual and psychological components of therapeutic interventions. Placebo control should meet two criteria: blinding efficacy (indistinguishable from active treatment) and physiological inertness. In the case of acupuncture, however, it is difficult to meet both criteria simultaneously. The dilemma of placebo needles suggests that placebo needles do not constitute proper control in acupuncture research. Considering the characteristics of placebo needles, patients are more likely to perceive placebo needles as active treatment in acupuncture trials compared to placebo pills in pharmaceutical trials. Placebo response might be observed more frequently to placebo needles than to placebo pills. When acupuncture treatments are utilized in clinical use, placebo effects can be enhanced by exploiting patients' expectations in the contextual or environmental cues that surround medical intervention. Conclusions: We have to consider these unique characteristics of placebo needles in order to avoid drawing premature conclusions that acupuncture itself is just a placebo.

• The Journal of Pediatrics of Korean Medicine
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• v.38 no.1
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• pp.55-77
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• 2024

Objectives This study aimed to analyze the registration status and characteristics of clinical trials on herbal medicine (HM) and medication interventions for simple obesity in children and adolescents. Methods All interventional clinical trials registered in the International Clinical Trials Registry Platform of the World Health Organization until December 12, 2024, were collected. The study design, interventions, inclusion and exclusion criteria, and outcome measures were extracted. Results A total of 24 clinical trials (23 medications and 1 HM) were analyzed. The most common study designs were single-center, randomized controlled, parallel, and phase 2. Placebo controls were used in 87.5% of the studies, blinding was used in 79.1%, and quadruple blinding was the most common. Informed consent was obtained from 70.8% of the participants. Among the oral medications (66.6%), metformin was the most common (25%). Among the non-oral medications (29.1%), exenatide (Bydureon) was the most common intervention (42.8%). Body mass index was the most commonly reported primary outcome measure (79.1%), with most assessments performed at 6 months. Conclusions Based on the characteristics of the medication interventional clinical trial design analyzed in this study, additional high-quality multicenter traditional Korean medicine trials need to be designed in the future.

• The Journal of Korean Medicine
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• v.41 no.1
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• pp.107-116
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• 2020

Objectives: To overcome the limitations of randomized controlled trials, many other trials design is tested. The n-of-1 trial is a promising research method in the field of Korean medicine because of this methodology can examine the optimal treatment for each patient strictly. Therefore, we reviewed the status of N-of-1 studies on herbal medicine. Methods: A systematic literature review was conducted based on the pubmed database. The search term were 'N-of-1 Trial', 'Chinese Medicine', 'Herbal Medicine', 'Kampo'. There was no restriction in year. Results: Four clinical trials have been identified to demonstrate the effectiveness of herbal medicines for Kidney-yin-deficiency syndrome, bronchiectasis and gastric cancer. These studies suggest that the N-of-1 design is a study that encourages patient involvement, demonstrates the effectiveness of herbal medicines and helps reduce unnecessary medication. Conclusion: The N-of-1 clinical trial may be a rigorous methodology suitable for the clinical setting and may help the development of evidence-based Korean medicine. Attention is also needed in this research method in Korea.

• The Journal of Korean Obstetrics and Gynecology
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• v.33 no.3
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• pp.119-135
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• 2020

Objectives: The purpose of this study is to confirm the effectiveness and safety of herbal medicine treatment for treating pregnancy-induced hypertension. Methods: We searched for randomized controlled trials of pregnancy-induced hypertension treated with herbal medicine, through nine databases. Interventions and results of the selected clinical studies were analyzed. Results: Eleven randomized controlled trials were finally included according to the inclusion and exclusion criteria. Treatment group was treated with herbal medicine alone in two studies, and with herbal medicine and western medicine in nine studies. Control group was treated with western medicine. Taxilli Ramulus (桑寄生) (54.5%) was the most frequently used herb in herbal medicine treatment. In all of eleven studies, treatment group was more effective for pregnancy-induced hypertension than the control group. Conclusions: This study suggested that herbal medicine treatment alone or combined with western medicine treatment could be helpful in improving the therapeutic effect on pregnancy-induced hypertension and reducing side effects as well. However, in order to obtain stronger evidence of herbal medicine treatment for pregnancy-induced hypertension, more high-quality and well-designed randomized controlled trials should be conducted.

• Korean Journal of Acupuncture
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• v.34 no.4
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• pp.209-230
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• 2017

Objectives : The aim of this study was to describe the details and to assess the clinical evidence of acupuncture and moxibustion for non-specific chronic neck pain. Methods : We searched seven databases including Korean, English, and Chinese databases through July 2016. Studies using acupuncture, moxibustion, pharmacopuncture, electroacupuncture, auricular-acupuncture, acupressure for non-specific chronic neck pain were included. Only controlled clinical trials or randomized clinical trials were assessed. Study design, number of subject, inclusion criteria, intervention, and results were extracted. In addition, details of intervention including needle type, retention time, acupoints were analyzed. Results : Total 64 studies(39 acupuncture, 9 laser, 6 pharmaco-acupuncture, 3 electro-acupuncture, 3 auricular-acupuncture, 3 moxibustion, 1 acupressure) were included. Among 39 acupuncture studies, 35 used acupuncture as sole intervention. Sham treatment was the most common intervention for control group, followed by no intervention. Various outcome including pain, disability, quality of life, range of motion was used as outcome measurement. The effect of acupuncture and moxibustion was different depending on the type of control and outcome measurement. The most commonly used method in acupuncture for neck pain was GB21, SI3, GB20, LI4, BL11 acupoints, 10~30 mm insertion depth, 20~30 retention time, and 1~2 times per week. Conclusions : Analyzing the details of acupuncture and moxibustion treatment could be helpful for researches and clinics. Further studies should consider the characteristics of study design, intervention, and outcome to assess the effect of TKM.

• The Journal of Korean Medicine
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• v.44 no.3
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• pp.189-200
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• 2023

Objectives: The purpose of this study is to analyze the current state of quantitative literature evidence for the prescription of 56 herbal medicines covered by health insurance that have been studied in Korea for the past 30 years, to evaluate the reliability of the evidence, and to find out the research direction of herbal medicine prescription in the future. Methods: 56 kinds of herbal medicine prescriptions were searched in domestic literature search databases OASIS, DBpia, and overseas PubMed, classified into chemistry, toxicity, cells, animals, clinical cases, and clinical trial studies, and built into an EBM pyramid structure. Results: When classified according to research contents, there were 61 cases (7.5%) of physicochemical analysis to identify constituent substances, 80 cases (9.8%) of toxicity evaluation, and 672 cases (82.7%) of efficacy evaluation. The efficacy evidence was classified according to the evidence-based medical pyramid structure: 196 cell trials (29.1%), 372 animal trials (55.4%), 89 case and case reporting series (13.3%), 7 comparative case studies (1.1%), and 8 randomized control clinical trials (1.2%). In the pyramid composition, the basis for the validity of 56 kinds of herbal medicines prescribed was 568 cases (84.5%) in cell and animal units, which could not be said to be highly reliable. There was no relationship between the ranking of quantitative literature evidence for herbal medicine prescriptions and the ranking of salary administration. Conclusions: In an era that continues to require scientific evidence for herbal medicine, traditional herbal medicine should secure the basis for safety validity even for the 10th most frequent prescription among 56 herbal medicine prescriptions for consumers. In particular, traditional herbal medicine should increase the quantitative and qualitative level of case reports on related herbal medicine prescriptions, focusing on each clinical society, and move toward comparative case studies and randomized clinical trial so that traditional herbal medicine is positioned as Evidence-based medicine.

• The Journal of Korean Obstetrics and Gynecology
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• v.30 no.2
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• pp.81-92
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• 2017

Objectives: This review aims to report the efficacy and safety of electroacupuncture in the treatment of primary dysmenorrhea. Methods: We searched for randomized controlled studies (RCTs) using electroacupuncture on primary dysmenorrhea up to Dec 2016. The following databases were searched : OASIS, PubMED, EMBASE, CENTRAL. The results of the studies were analyzed and the risk of bias was assessed. Results: Five studies were included in this review. In most studies, the effect of electroacupuncture at Sameumgyo (SP6) was better than that of electroacupuncture at Hyeonjong (GB39), nonacupoint and no intervention about Visual analog scale (VAS), Verbal rating scale (VRS) and Retrospective symptom scale (RSS). But there were no significant effects on Resistance Index (RI) and S/D ratio (the ratio between peak systolic to end-diastolic flow velocity in uterine arteries). Serous adverse events were not reported. Conclusions: This review shows that electroacupuncture is effective on primary dysmenorrhea with no serious adverse events.

• Journal of Korean Medicine Rehabilitation
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• v.29 no.2
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• pp.171-188
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• 2019

Objectives The purpose of this thesis is to compare and analyze outcomes of case studies and controlled studies about Hwangryunhaedok-tang (HHT) pharmacopuncture in clinical studies. Based on these studies reporting clinical effects by using HHT pharmacopuncture, we object to deduct the comparative review in applying clinical disorders limitedly. And conclusionally, by using this comparative review, we aim to make the fine evidence in treating clinical specific diseases. Methods We searched 106 studies about HHT pharmacopuncture from 6 Korean web databases by using in Korean word 'Hwangryunhaedok-tang pharmacopuncture'. This search had been progressed throughout 1 month (January, 2019). There was 106 thesis and we excluded studies that are not related to HHT pharmacopuncture, experimental research, not the case report or randomized controlled trials, non-randomized controlled trials, not using HHT pharmacopuncture, not using only one pharmacopuncture, and not using HHT pharmacopuncture for major treating method. As a result, 39 thesis are selected as a population. Results We analyzed 34 case reports and 5 controlled studies. As the final outcome, HHT pharmacopuncture was used in musculoskeletal diseases, dermatopathy, and 32 specific diseases. Conclusions After analyzing 39 studies, effective symptom changes clinically and statistically by using HHT pharmacopuncture herbal acupuncture were identified. However, these thesis designs were reported deficiently in many parts such as not excluding other confounding variables. After modifying defects of thesis design and conduct study, it can play a role as the evidence using HHT pharmacopuncture more precisely.

• Journal of Korean Medicine Rehabilitation
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• v.29 no.3
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• pp.61-74
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• 2019

Objectives This study aimed to review clinical studies about Korean medicine used in peroneal nerve palsy. Methods In 11 online databases (Earticle, Research Information Sharing Service, Oriental Medicine Advanced Searching Integrated System, KMbase, Korean Traditional Knowledge Portal, National Digital Science Library, MEDLINE/Pubmed, Ebscohost, Cochrane CENTRAL, EMBASE, China National Knowledge Infrastructure), we searched clinical studies about Korean medicine. Among the studies that we've searched, we excluded the studies that are not related to Korean medicine, case reports, randomized controlled trials and retrospective studies. As a result, 16 case studies and 1 randomized controlled trial are included. Results Total number of patients was 123. In these studies, acupuncture (100%), herbal medicine (58.8%), pharmacopuncture (58.8%), Korean physical therapy (58.8%), moxibustion (41.1%), cupping (41.1%) etc. were used. In acupuncture, GB34 and ST36 were most frequently used. Most of the herbal medicines used in these studies were different. Range of movement were most frequently used in outcome measure. Conclusions In this study, we reviewed studies about Korean medicine used in peroneal nerve palsy. It was difficult to clearly determine which intervention has improved the symptom. In the future, Further clinical studies will be needed to retain the evidence for the treatment of peroneal nerve palsy. And also more randomized controlled clinical trials to prove the efficacy of Korean medicine will be needed.